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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K952315
Device Name SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE
Applicant
EMG SCIENTIFIC
1461 SOUTH LIVONIA
LOS ANGELES,  CA  90035 -3317
Applicant Contact SHMUEL EINSTEIN
Correspondent
EMG SCIENTIFIC
1461 SOUTH LIVONIA
LOS ANGELES,  CA  90035 -3317
Correspondent Contact SHMUEL EINSTEIN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/17/1995
Decision Date 12/04/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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